| General information |
| Database: | DB00422 |
| Objective: | etuximab plus irinotecan/folinic acid/5fluorouracil (5FU) (IF) was evaluated as firstline treatment of patients with advanced gastric cancer and gastroesophageal junction tumors. Preplanned analyses of the influence of tumor biomarkers on treatment outcome were carried out. |
| Authors: | Moehler M, et al |
| Title: | Cetuximab with irinotecan, folinic acid and 5fluorouracil as firstline treatment in advanced gastroesophageal cancer: a prospective multicenter biomarkerorientedphase II study. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 21119032 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | adenocarcinoma of the stomach or gastroesophageal junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cetuximab with irinotecan, folinic acid and 5fluorouracil |
| Study Type: | prospective multicenterbiomarkerorientedphase II study |
| Key Patients Feature: | patients were required to have histologically proven adenocarcinoma of thestomach or gastroesophageal junction according to the response evaluationcriteria in solid tumors (RECIST) [19] with advanced or metastatic disease, an Eastern Cooperative Oncology Group performance status of 0-2, a lifeexpectancy >12 weeks and adequate hematological, hepatic and renalfunction and at least 4 weeks since the last surgical procedure. |
| Biomarker: | epidermal growth factor receptorexpressing;tumor PTEN expression |
| Biomark Analysis: | Tumor response was more common than nonresponse in epidermal growth factor receptorexpressing tumors (P = 0.041). Tumor PTEN expression was associated with longer PFS (P = 0.035) and OS (P = 0.0127) than no PTEN expression. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received weekly cetuximab (400 mg/m(2) on day 1, subsequently 250 mg/m(2)) plus irinotecan (80 mg/m(2)) and a 24hour continuous infusion of folinic acid (200 mg/m(2)) and 5FU (1500 mg/m(2)) on days 1, 8, 15, 22, 29 and 36 of a 50day cycle, until progressive disease (PD). |
| Primary End Point: | the ORR according to the RECIST criteria |
| Secondary End Point: | PFS and 1year survival rate |
| Patients Number: | 49 |
| Trial Results |
| DLT_MTD: | The most common grade 3/4 toxic effects in 49 patients were diarrhea (15%) and skin toxic effects (14%). |
| Objective Response Rate: | the overall response rate was 46% and disease control rate was 79%. Median progression freesurvival (PFS) and overall survival (OS) was 9.0 months [95% confidence interval (CI) 7.1-15.6] and 16.5 months(95% CI 11.7-30.1), respectively. Tumor response was more common than nonresponse in epidermal growth factorreceptorexpressing tumors (P = 0.041) |
| Disease Control Rate: | 0.79 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.0 months [95% confidence interval (CI) 7.1-15.6] |
| Median OS A vs. C: | 16.5 months (95% CI 11.7-30.1) |
| Adverse Event(agent arm): | The most common grade 3/4 toxic effects in 49 patients were diarrhea (15%) and skin toxic effects (14%). |
| Conclusions: | etuximab plus IF was well tolerated and efficacy data they were encouraging. This treatment combination and the role of selected biomarkers are under investigation in the ongoingphase III EXPAND trial. |